• Dosage of Moxifloxacin HEC Pharm in details
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Dosage of Moxifloxacin HEC Pharm in details

Moxifloxacin HEC Pharm Dosage

Generic name: Moxifloxacin HEC Pharm HYDROCHLORIDE 400mg in 250mL

Dosage form: tablet, film coated; injection, solution

See also:

• Moxifloxacin HEC Pharm ABC Pack tablet, injection
• Moxifloxacin HEC Pharm Injection injection, solution; tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Dosage in Adult Patients

The dose of Moxifloxacin HEC Pharm is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

Table 1: Dosage and Duration of Therapy in Adult Patients

Type of Infectiona	Dose Every 24 hours	Durationb (days)
Community Acquired Pneumonia (1.1)	400 mg	7–14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.2)	400 mg	7
Complicated SSSI (1.3)	400 mg	7–21
Complicated Intra-Abdominal Infections (1.4)	400 mg	5–14
Plague (1.5)C	400 mg	10–14
Acute Bacterial Sinusitis (ABS) (1.6)	400 mg	10
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) (1.7)	400 mg	5

a)

Due to the designated pathogens.

b)

Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician

c)

Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Conversion of

Intravenous to

Oral Dosing in Adults

Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacin HEC Pharm Injection may be switched to Moxifloxacin HEC Pharm Tablets when clinically indicated at the discretion of the physician.

Important Administration Instructions

Moxifloxacin HEC Pharm Tablets

With Multivalent Cations

Administer Moxifloxacin HEC Pharm Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.

With Food

Moxifloxacin HEC Pharm Tablets can be taken with or without food, drink fluids liberally.

Moxifloxacin HEC Pharm Injection

Administer by

Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Avoid rapid or bolus intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard any unused portion because the premix flexible containers are for single-use only.

Drug and Diluent Compatibilities

Because only limited data are available on the compatibility of Moxifloxacin HEC Pharm intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin HEC Pharm Injection or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of Moxifloxacin HEC Pharm Injection with an infusion solution compatible with Moxifloxacin HEC Pharm Injection as well as with other drug(s) administered via this common line.

Compatible

Intravenous Solutions: Moxifloxacin HEC Pharm Injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1:

0.9% Sodium Chloride Injection, USP

1 Molar Sodium Chloride Injection

5% Dextrose Injection, USP

Sterile Water for Injection, USP

10% Dextrose for Injection, USP

Lactated Ringer’s for Injection

Preparation for Administration of Moxifloxacin HEC Pharm Injection

Refer to complete directions that have been provided with the administration set.

To prepare Moxifloxacin HEC Pharm Injection premix in flexible containers:

Close flow control clamp of administration set.

Remove cover from port at bottom of container.

Insert piercing pin from an appropriate transfer set (for example, one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.

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• Bacterial Infection
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What other drugs will affect Moxifloxacin HEC Pharm?

Some medicines can make Moxifloxacin HEC Pharm much less effective when taken at the same time. If you take any of the following medicines, take your Moxifloxacin HEC Pharm dose 4 hours before or 8 hours after you take the other medicine:

• the ulcer medicine sucralfate, or antacids that contain calcium, magnesium, or aluminum (such as Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Tums, and others);

• didanosine (Videx) powder or chewable tablets;

• lanthanum carbonate or sevelamer; or

• vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.

Tell your doctor about all your other medicines, especially:

• erythromycin;

• a blood thinner (warfarin, Coumadin, Jantoven);

• a diuretic or "water pill";

• heart rhythm medication;

• insulin or oral diabetes medicine (check your blood sugar regularly);

• medicine to treat depression or mental illness;

• steroid medicine (such as prednisone); or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect Moxifloxacin HEC Pharm, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

See also:

Moxifloxacin HEC Pharm drug interactions (in more detail)

Moxifloxacin HEC Pharm interactions

Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin HEC Pharm was proven: Atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.

Antacids, Minerals and Multivitamins: Concomitant ingestion of Moxifloxacin HEC Pharm with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin HEC Pharm after oral administration due to formation of chelate complexes with the multivalent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, antacids, antiretroviral drugs (eg, didanosine) and other preparations containing magnesium or aluminium, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral Moxifloxacin HEC Pharm dose.

Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin HEC Pharm. Absorption parameters (C_max, t_max, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin HEC Pharm uptake from the gastrointestinal tract.

Calcium Supplements: When given with high dose calcium supplements, only a slightly reduced rate of absorption was observed, while extent of absorption remained unaffected. The effect of high-dose calcium supplements on the absorption of Moxifloxacin HEC Pharm is considered as clinically not relevant.

Theophylline: In accordance with in vitro data, no influence of Moxifloxacin HEC Pharm on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin HEC Pharm does not interfere with the 1A2 subtypes of the CYP450 enzymes.

Warfarin: No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed.

Changes in International Normalized Ratio (INR): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacin HEC Pharm. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin HEC Pharm and warfarin was not demonstrated in clinical trials, INR monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.

Oral Contraceptives:

No interaction has occured following concomitant oral administration of Moxifloxacin HEC Pharm with oral contraceptives.

Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin HEC Pharm.

Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin HEC Pharm treatment. Pharmacokinetics of Moxifloxacin HEC Pharm were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin HEC Pharm and vice versa.

Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin HEC Pharm (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin HEC Pharm increased C_max of digoxin by approximately 30% at steady state without affecting AUC or trough levels.

Morphine:

Parenteral administration of morphine with Moxifloxacin HEC Pharm did not reduce the oral bioavailability of Moxifloxacin HEC Pharm and only slighlty decreased C_max (17 %).

Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin HEC Pharm. Following single dose administration in healthy subjects, AUC was marginally increased (by approximately 4%) and peak concentrations were decreased by 10%.

Probenecid: No significant effect on apparent total body clearance and renal clearance of Moxifloxacin HEC Pharm was found in a clinical study investigating the impact of probenecid on renal excretion.

Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin HEC Pharm 400 mg reduced the systemic availability of the drug by >80% by preventing absorption in vivo. The application of activated charcoal in the early absorption phase prevents further increase of systemic exposure in cases of overdose.

After IV drug administration, carbo medicinalis only slightly reduces systemic exposure (approximately 20%).

Food and Dairy Products: Absorption of Moxifloxacin HEC Pharm was not altered by food intake (including dairy products). Moxifloxacin HEC Pharm can be taken independent from food intake.

Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.

References

1. FDA/SPL Indexing Data. "U188XYD42P: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology